111. FDA Exemptions from Requirements for IND (§312.2)

The clinical investigation of a drug product that is lawfully marketed in the United States may be exempt from the requirements for an IND if all of the following conditions are true:

The investigation is not intended to be reported to FDA in support of a new indication for use or to support any other significant change in the labeling for the drug.

The investigation is not intended to support a significant change in the advertising for the product.

The investigation does not involve a route of administration or dosage level, use in a subject population, or other factor that significantly increases the risks (or decreases the acceptability of the risks) associated with the use of the drug product.

The research is conducted in compliance with the requirements for IRB review and informed consent (§56 and 50, respectively).

The investigation is conducted in compliance with the requirements concerning the promotion and sale of drugs (§312.7).

The investigation does not intend to invoke §50.24 for the exception from informed consent requirements for emergency research.

Two other situations allow clinical investigations to be exempt from IND requirements:

The clinical investigation is for an in vitro diagnostic test that

involves one or more of these biological products

Blood grouping serum,

Reagent red blood cells, or

Anti-human globulin;

is intended for use in a diagnostic procedure that confirms the diagnosis made by another, medically established, diagnostic product or procedure; and

the diagnostic test is shipped in compliance with §312.160.

The clinical investigation involves use of a placebo and the investigation does not otherwise require submission of an IND.